FDA refuses to review Moderna’s mRNA flu vaccine

Moderna received a refusal-to-file (RTF) letter from the FDA’s Center for Biologics Evaluation and Research (CBER) for its investigational mRNA vaccine for influenza, the company said Tuesday. The letter is inconsistent with the feedback received at pre-Phase 3 and pre-submission consultations, Moderna said. The company has requested a meeting with the FDA. The vaccine, mRNA-1010,… The post FDA refuses to review Moderna’s mRNA flu vaccine appeared first on Drug Discovery and Development.

Continue reading →